FDA label 4bce6b8a-9804-4676-9bd3-6d0ce7006e17

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
f2fff324-bbb8-405a-b085-460afbaba097
SPL ID
4bce6b8a-9804-4676-9bd3-6d0ce7006e17
Version
2
Effective date
2016-10-11
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:30:16

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings L iver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes • more than 4 doses in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly. Do Not Use • in a child under 4 years of age • if your child is allergic to acetaminophen • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. • for the purpose of making your child sleepy Ask a doctor before use if your child has • liver disease • glaucoma • a breathing problem such as chronic bronchitis • cough that occurs with too much phlegm (mucus) • chronic cough that lasts, such as occurs with asthma Ask a doctor or pharmacist before use if your child is taking • sedatives or tranquilizers • the blood thinning drug warfarin When using this product • do not exceed recommended dosage • marked drowsiness may occur • sedatives and tranquilizers may increase drowsiness • excitability may occur, especially in children Stop use and ask a doctor if • pain or cough gets worse or lasts more than 5 days • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • cough comes back or occurs with a fever, rash or persistent headache. These could be signs of a serious condition. Keep Out of Reach of Children In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.